DALLAS - Spectral AI, Inc. (NASDAQ:MDAI), a company specializing in artificial intelligence for medical diagnostics, has recently completed a proof-of-concept for a module within its DeepView® System, which aims to enhance the treatment decisions in burn care. The module is designed to accurately calculate the total body surface area (TBSA) affected by burns, which is critical for immediate and precise treatment.
The current standard for wound size measurement often falls short in its ability to measure the three dimensions of a wound - distance, area, and volume. This can lead to inaccuracies in wound sizing and consequentially, suboptimal treatment decisions. Spectral AI's new technology, integrated into the DeepView AI®-Burn, addresses this issue by using image capture to provide sub-millimetric accuracy in assessing burn wounds without the need for external markers or manual placement of stickers.
According to Peter M. Carlson, CEO of Spectral AI, the technology provides a more comprehensive representation of an acute burn injury than current methods. He believes the new technology will improve the standardization and uniformity of burn care and help reduce human error, offering crucial support to clinicians across various care settings.
The DeepView® System is designed to differentiate between healing and non-healing tissue, providing a binary prediction of wound healing potential on the first day, which can inform clinical decision-making. Spectral AI aims to revolutionize wound care management by providing an objective assessment of a wound's healing potential before any treatment or medical intervention.
The Dallas-based company is focused on predictive AI for faster and more accurate treatment decisions, with initial applications targeting patients with burns and diabetic foot ulcers. The DeepView® System is part of the company's effort to change the current standard of care in wound treatment by providing timely and accurate treatment insights.
This announcement is based on a press release statement from Spectral AI, Inc. and reflects the company's commitment to advancing medical diagnostics through AI technology. As the technology progresses, it may potentially alter how clinicians approach burn wound treatment, aiming for improved patient outcomes and reduced healthcare costs.
In other recent news, Spectral AI, Inc. has been making significant strides in its operations. The company has completed patient enrollment for its U.S. Burn Pivotal Study, which aims to validate the AI-driven algorithm of its DeepView® System for burn indication. Spectral AI plans to submit a De Novo request to the FDA in the second quarter of 2025 for classification of DeepView AI®-Burn as a Class II medical device.
Additionally, Spectral AI has secured over $850,000 from the Medical Technology Enterprise Consortium for the development of its handheld predictive burn wound healing device, DeepView SnapShot M®. The company's R&D revenue has seen a significant increase, with projections for full-year 2024 R&D revenue to be approximately $28 million, marking a 55% year-over-year increase, according to an analysis by BTIG.
Furthermore, Spectral AI's patent portfolio has grown by 30%, now totaling 26 patents, which are integral to the company's future commercialization initiatives. The company has also expanded its clinical trial sites for the 2024 Burn Pivotal Study, adding the University of California San Diego and the University of Utah to its network.
In response to concerns over possible manipulative trading practices affecting its stock, Spectral AI, led by board member and largest shareholder, Erich Spangenberg, has urged Nasdaq and state securities regulators in Florida, Louisiana, and Texas to investigate. These are recent developments for Spectral AI.
InvestingPro Insights
While Spectral AI's innovative DeepView® System shows promise in revolutionizing burn care management, investors should be aware of the company's current financial situation. According to InvestingPro data, Spectral AI has a market capitalization of $17.78 million, reflecting its small-cap status in the medical technology sector.
The company's revenue for the last twelve months as of Q2 2023 stands at $22.53 million, with a modest revenue growth of 0.3% over the same period. However, it's worth noting that the quarterly revenue growth in Q2 2023 was significantly higher at 75.91%, which could indicate improving sales momentum for their AI-driven diagnostic tools.
Despite these positive indicators, InvestingPro Tips highlight some challenges. The company is not currently profitable, with a negative P/E ratio of -1.36 for the last twelve months as of Q2 2023. This aligns with another InvestingPro Tip suggesting that analysts do not anticipate the company to be profitable this year.
The stock's recent performance has been concerning, with InvestingPro data showing a 30.82% price decline over the past month and a 45.99% drop over the last three months. This downward trend is further emphasized by an InvestingPro Tip indicating that the stock has taken a significant hit over the last week.
For investors interested in a deeper analysis, InvestingPro offers 8 additional tips for Spectral AI, providing a more comprehensive view of the company's financial health and market position.
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